Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients: a Single-arm, Multicenter, Phase II Clinical Trial（Rocket Trial）
This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of orelabrutinib combined with the R-CHOP (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisone) regimen as first-line treatment in CD5-positive diffuse large B-cell lymphoma (DLBCL) patients.
• Subjects fully understand and voluntarily participate in this study and sign informed consent.
• Aged ≥18 years, both male and female.
• Pathologically confirmed CD5-positive DLBCL
• There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
• Eastern Cooperative Oncology Group(ECOG) performance status score of 0-2.
• Expected survival ≥3 months.
• Sufficient bone marrow, liver, and kidney function.